HIV-1-infectionPhase 2NCT03539224
Antiretroviral Treatment Guided by Proviral Genotype: Pilot Trial of Proof of Concept.
A Phase 2 study testing Dolutegravir (DTG) and Lamivudine (3TC) in people with HIV-1-infection, run by Instituto de Investigación Hospital Universitario La Paz at 2 sites in Spain.
Trial summary
Phase IIa, open clinical trial, pilot, single arm and proof of concept. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Dolutegravir (DTG) and Lamivudine (3TC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesSpain
- Study dates
- 2 Nov 2017to 31 Jul 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infected patients.
- Age> 18 years.
- Receiving stable antiretroviral treatment for at least 3 months.
- Current or historical treatment with 3TC or FTC.
- Willing to change antiretroviral treatment due to intolerance or interest in simplification.
- Undetectable viral load (<50 cop/mL) for at least 1 year prior to the inclusion. A single viral load >50cop/ml (≤500 copies/ml) is allowed before the three months prior to inclusion in the study, preceded and followed by an undetectable determination.
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- Current level of CD4> 350 cells/μL.
- Naïve to integrase inhibitors.
- Patient able to understand and give written informed consent.
- For those included in group 1 (20 patients): No previous history of virological failure with ART regimen that included 3TC or FTC or previous virological failure had a population genotype without M184V/I or K65R/E/N mutations.
- For those included in group 2 (20 patients): previous history of virological failure with ART regimen that included 3TC or FTC and historical genotype with M184V/I or K65R/E/N mutations.
Who cannot join
- Detection of any of the following mutations in proviral DNA in peripheral blood by conventional sequencing: M184V/I or K65R/E/N.
- Pregnant, lactating or child-bearing women who do not commit to using an adequate contraceptive method.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
About this study
Phase IIa, open clinical trial, pilot, single arm and proof of concept.
Read the detailed description
Proof of concept trial evaluating safety and efficacy of treatment with Dolutegravir (DTG) + lamivudine (3TC) once daily in suppressed participants with history of previous treatment with 3TC or emtricitabine (FTC). Half of the participants will have history of failure with 3TC or FTC and M184V/I or K65R/E/N mutations in previous plasma genotypes, although to be eligible these mutations cannot be detectable at study entry in proviral DNA.
- Conditions
- HIV-1-infection
- Being tested
- Dolutegravir (DTG), Lamivudine (3TC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir (DTG)Drug
Also called Tivicay
DTG 50 mg tablet will be orally administered once daily with or without food upto 48 weeks
Lamivudine (3TC)Drug
Also called Epivir
Lamivudine will be dispensed as 300 mg white, diamond shaped, scored, film coated tablets. It will be orally administered once daily with or without food upto 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dolutegravir (DTG) + Lamivudine (3TC) | Experimental | Eligible subjects will receive one 50 mg tablet of DTG plus 300 mg 3TC tablet orally once daily upto 48 weeks Receives: Drug: Dolutegravir (DTG); Drug: Lamivudine (3TC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with undetectable viral load (<50 copies / mL) at 48 weeks
- Efficacy: Proportion of patients with undetectable viral load (<50 copies / mL) at 48 weeks of follow-up, according to the FDA snapshot algorithm in the population "by intention to treat-exposed". The intention-to-treat population includes all patients who have received at least one dose of DTG and 3TC.
Measured: Week 48
Secondary outcomes (4)
Proportion of patients with virological failure at 24 weeks
Proportion of patients with viral load <50 copies/ml at week 24, according to the FDA snapshot algorithm in the population "by intention to treat-exposed".
Measured: Week 24
Proportion of patients with virological failure at 48 weeks
Proportion of patients with virological failure at week 48 according to the FDA snapshot algorithm.
Measured: Week 48
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of adverse events and discontinuation of treatment due to toxicity or intolerance.
Measured: Since baseline visits to week 48
Evaluation of the appearance of genotypic resistance mutations (1)
Incidence of genotypic resistance mutations in patients with virological failure at week 48. Description and frequency of genotypic resistance mutations.
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start2 Nov 2017
- Primary completion31 May 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm opened with Intervention Type of Drug: Dolutegravir (DTG) and Lamivudina (3TC)
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539224
- Sponsor's protocol ID
- ART-PRO
- Other IDs
- 2017-000151-10, 2017
- Status last verified
- Jul 2020
- First submitted
- 2 Apr 2018
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Miguel Buckley R, Rial-Crestelo D, Montejano R, Pinto A, Jimenez-Gonzalez M, Lagarde M, Esteban-Cantos A, Aranguren-Rivas P, Cadinanos J, Bisbal O, Castro JM, Santacreu-Guerrero M, Bermejo-Plaza L, Moreno V, Hernando A, Martin-Carbonero L, Rubio R, Delgado R, Arribas JR, Pulido F; Antiretroviral Treatment Guided by Proviral Genotype (ART-PRO) Study Group. Long-term Evaluation of Residual Viremia in a Clinical Trial of Dolutegravir Plus Lamivudine as Maintenance Treatment for Participants With and Without Prior Lamivudine Resistance. Open Forum Infect Dis. 2022 Nov 8;9(11):ofac610. doi: 10.1093/ofid/ofac610. eCollection 2022 Nov.
PubMed 36447613De Miguel R, Rial-Crestelo D, Dominguez-Dominguez L, Montejano R, Esteban-Cantos A, Aranguren-Rivas P, Stella-Ascariz N, Bisbal O, Bermejo-Plaza L, Garcia-Alvarez M, Alejos B, Hernando A, Santacreu-Guerrero M, Cadinanos J, Mayoral M, Castro JM, Moreno V, Martin-Carbonero L, Delgado R, Rubio R, Pulido F, Arribas JR; ART-PRO, PI16/00837-PI16/00678 study group. Dolutegravir plus lamivudine for maintenance of HIV viral suppression in adults with and without historical resistance to lamivudine: 48-week results of a non-randomized, pilot clinical trial (ART-PRO). EBioMedicine. 2020 May;55:102779. doi: 10.1016/j.ebiom.2020.102779. Epub 2020 May 11.
PubMed 32408111
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiretroviral Treatment Guided by Proviral Genotype: Pilot Trial of Proof of Concept.
- ClinicalTrials.gov ID
- NCT03539224
- Acronym / sponsor ID
- ART-PRO
- Conditions
- HIV-1-infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase IIa, open clinical trial, pilot, single arm and proof of concept.
Detailed description
Proof of concept trial evaluating safety and efficacy of treatment with Dolutegravir (DTG) + lamivudine (3TC) once daily in suppressed participants with history of previous treatment with 3TC or emtricitabine (FTC). Half of the participants will have history of failure with 3TC or FTC and M184V/I or K65R/E/N mutations in previous plasma genotypes, although to be eligible these mutations cannot be detectable at study entry in proviral DNA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm opened with Intervention Type of Drug: Dolutegravir (DTG) and Lamivudina (3TC)
| Arm | Type | Receives |
|---|---|---|
| Dolutegravir (DTG) + Lamivudine (3TC) | Experimental | Drug: Dolutegravir (DTG), Drug: Lamivudine (3TC)Eligible subjects will receive one 50 mg tablet of DTG plus 300 mg 3TC tablet orally once daily upto 48 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- HIV-1 infected patients.
- Age> 18 years.
- Receiving stable antiretroviral treatment for at least 3 months.
- Current or historical treatment with 3TC or FTC.
- Willing to change antiretroviral treatment due to intolerance or interest in simplification.
Key exclusion criteria (2 listed)
- Detection of any of the following mutations in proviral DNA in peripheral blood by conventional sequencing: M184V/I or K65R/E/N.
- Pregnant, lactating or child-bearing women who do not commit to using an adequate contraceptive method.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dolutegravir (DTG)Also: TivicayDTG 50 mg tablet will be orally administered once daily with or without food upto 48 weeks | Drug | Dolutegravir (DTG) + Lamivudine (3TC) |
| Lamivudine (3TC)Also: EpivirLamivudine will be dispensed as 300 mg white, diamond shaped, scored, film coated tablets. It will be orally administered once daily with or without food upto 48 weeks. | Drug | Dolutegravir (DTG) + Lamivudine (3TC) |
Primary outcome
Proportion of patients with undetectable viral load (<50 copies / mL) at 48 weeks
Time frame: Week 48
- Efficacy: Proportion of patients with undetectable viral load (<50 copies / mL) at 48 weeks of follow-up, according to the FDA snapshot algorithm in the population "by intention to treat-exposed". The intention-to-treat population includes all patients who have received at least one dose of DTG and 3TC.
4 secondary outcomes
Proportion of patients with virological failure at 24 weeks
Time frame: Week 24
Proportion of patients with virological failure at 48 weeks
Time frame: Week 48
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Since baseline visits to week 48
Evaluation of the appearance of genotypic resistance mutations (1)
Time frame: Week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Derived from this study: PubMed 36447613De Miguel Buckley R, Rial-Crestelo D, Montejano R, Pinto A, Jimenez-Gonzalez M, Lagarde M, Esteban-Cantos A, Aranguren-Rivas P, Cadinanos J, Bisbal O, Castro JM, Santacreu-Guerrero M, Bermejo-Plaza L, Moreno V, Hernando A, Martin-Carbonero L, Rubio R, Delgado R, Arribas JR, Pulido F; Antiretroviral Treatment Guided by Proviral Genotype (ART-PRO) Study Group. Long-term Evaluation of Residual Viremia in a Clinical Trial of Dolutegravir Plus Lamivudine as Maintenance Treatment for Participants With and Without Prior Lamivudine Resistance. Open Forum Infect Dis. 2022 Nov 8;9(11):ofac610. doi: 10.1093/ofid/ofac610. eCollection 2022 Nov.
- Derived from this study: PubMed 32408111De Miguel R, Rial-Crestelo D, Dominguez-Dominguez L, Montejano R, Esteban-Cantos A, Aranguren-Rivas P, Stella-Ascariz N, Bisbal O, Bermejo-Plaza L, Garcia-Alvarez M, Alejos B, Hernando A, Santacreu-Guerrero M, Cadinanos J, Mayoral M, Castro JM, Moreno V, Martin-Carbonero L, Delgado R, Rubio R, Pulido F, Arribas JR; ART-PRO, PI16/00837-PI16/00678 study group. Dolutegravir plus lamivudine for maintenance of HIV viral suppression in adults with and without historical resistance to lamivudine: 48-week results of a non-randomized, pilot clinical trial (ART-PRO). EBioMedicine. 2020 May;55:102779. doi: 10.1016/j.ebiom.2020.102779. Epub 2020 May 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dolutegravir (DTG) and Lamivudine (3TC) in people with HIV-1-infection, run by Instituto de Investigación Hospital Universitario La Paz at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with undetectable viral load (<50 copies / mL) at 48 weeks (time frame: Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03539224, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.